Measure of Performances of CT Colonography With Computer-Aided Detection (CAD) as Second Reader in Detecting Colorectal Lesion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 651
- 主要终点
- Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
研究概览
简要总结
RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity.
PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.
详细描述
Design: multicenter, cross-sectional study. Each participant underwent CT colonography and colonoscopy on the same day. Expert readers interpreted CT colonography unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening
排除标准
- •clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome
- •inflammatory bowel disease
- •celiac disease
- •evidence of increased risk of harm from colonoscopy
- •psychological or physical conditions that contraindicated colonoscopy or CT Colonography
结局指标
主要结局
Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 6 to 9 mm
Specificity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with no clinical relevant lesions
次要结局
- Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting individuals with lesions 10 mm or larger
- Sensitivity of CT colonography with unassisted and CAD-assisted reading in detecting lesions 6 mm or larger